The chance of relapse or recurrence for patients with early-stage, high grade uterine leiomyosarcoma is approximately 50% to 70%, and recurrences can be distant and / or local. Currently, for women with completely resected high grade leiomyosarcoma that is confined to the uterus, the standard treatment is observation. So far, no prospective, randomized clinical trial has shown any interventions that are capable of improving recurrence-free or overall survival in these patients.
Dr. Petronella Ottevanger of the Radboud University Nijmegen Medical Centre, The Netherlands, Secretary of the EORTC Gynecological Cancer Group, and Coordinator of this study says, “The killing potential of this disease deserves a proper randomized investigation of the potential benefits of adjuvant chemotherapy.”
The phase III randomized EORTC 55116 – 62114 trial has now opened to answer the question of whether adjuvant chemotherapy might improve survival for women with this disease. Following complete resection of the leiomyosarcoma, women in the chemotherapy arm of this trial will receive gemcitabine plus docetaxel followed by doxorubicin. Patients in the control arm will be assigned to observation, the standard practice.
The primary objective of this trial is to see if overall survival of patients receiving adjuvant chemotherapy is superior to that of patients receiving standard practice. Secondary objectives include seeing whether adjuvant chemotherapy improves recurrence-free survival as well as exploring the impact of potential predictors of recurrence or death (e.g. age, size of the tumor, absence or presence of cervical involvement, and mitotic rate).
Dr. Anders Krarup-Hansen of the Herlev Hospital at the University Copenhagen, Denmark, and Principal Investigator for the EORTC Soft Tissue and Bone Sarcoma Group in this study says, “This important problem will now be solved in a large scale cooperative phase III trial, I do hope this kind of set up will be a model for future trials in sarcomas.”
EORTC trial 55116 – 62114 plans to accrue 216 patients and will be conducted in multiple sites located in eleven countries: Belgium, Canada, Denmark, France, Germany, Italy, Norway, Spain, The Netherlands, the United States of America, and the United Kingdom. This intergroup trial is led by the Gynecological Cancer Group USA in collaboration with the EORTC Gynecological Cancer and Soft Tissue and Bone Sarcoma Groups and NCRN (Cancer Research UK). Uterine leiomyosarcoma is a rare cancer, and this study is part of International Rare Cancer Initiative (IRCI). This trial is supported by the United States National Cancer Institute.
For more information concerning EORTC trial 55116 – 62114 please contact: www.eortc.org/contact
John Bean, PhD
EORTC, Medical Science Writer